Cleared Special

K033899 - LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR

K033899 is an FDA 510(k) clearance for LIFESTREAM PLUS CHOLESTEROL MONITOR, manufactured by Lifestream Technologies, Inc.. The device is a Class 1 Chemistry device with product code NFX cleared through the Special 510(k) pathway after a 155-day FDA review.

K033899 · Lifestream Technologies, Inc. · Chemistry device
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May 2004
Decision
155d
Days
Class 1
Risk

K033899 is an FDA 510(k) clearance for the LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL M.... Classified as Test, Cholesterol, Total, Over The Counter (product code NFX), Class I - General Controls.

Submitted by Lifestream Technologies, Inc. (Post Falls, US). The FDA issued a Cleared decision on May 20, 2004 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033899

510(k) Number K033899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2003
Decision Date May 20, 2004
Days to Decision 155 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

NFX Device Classification - Class 1, General Controls

Product Code NFX Test, Cholesterol, Total, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

K033899 · LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
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